Label Updates May Be Allowed for Generics

By KATIE THOMAS

November 8, 2013

The Food and Drug Administration proposed a rule on Friday that would permit generic drug makers to update their labels if they received information about potential safety problems. The move puts the companies on equal footing with brand-name manufacturers, but it also opens the door to lawsuits against them for the first time since the Supreme Court barred such cases two years ago.

Until now, only brand-name drug makers had the ability to independently update their labels if important new information surfaced about one of their drugs. If the F.D.A. agreed that the new information warranted a change in the label, then generic companies were required to update their product information so that it would be identical to the branded drug’s labeling.

Dr. Janet Woodcock, the F.D.A.’s head of drug evaluation and research, said the proposed change would create better parity between brand-name drug manufacturers and generic companies, which is especially important given that more than 80 percent of prescriptions in the United States are currently dispensed as generic drugs. “Now, with the generic industry having grown up, most people are taking generic drugs,” she said in a telephone interview. “It’s really time to level the playing field.”

The rule would also pave the way for lawsuits from patients who could now claim that generic companies did not sufficiently warn them of a drug’s dangers. In 2011, the Supreme Court ruled that such lawsuits were not valid because generic companies were required to use the same label warnings as brand-name manufacturers and thus could not be blamed for failing to warn patients about the risks of taking their drugs.

“This is an important consumer protection provision,” said Representative Chris Van Hollen, Democrat of Maryland, who had supported such a change. “It’s a long time in coming.”

The Generic Pharmaceutical Association, the industry trade group, said it was still reviewing the regulation but was concerned that the change could create confusion. In a statement, Ralph G. Neas, the association’s president, said the group was “very concerned that multiple versions of critical safety information would lead to unnecessary confusion and uncertainty for prescribers and other health care professionals, with harmful consequences for patients.”

Mr. Neas also raised the question of whether the rule was legal. “The Supreme Court has repeatedly held that generic pharmaceutical manufacturers must duplicate the language on the brand pharmaceutical manufacturer’s labels and cannot make changes to a label without F.D.A. approval,” he said in the statement. “Therefore, the agency’s authority to enact a rule that differs from the federal law is unclear.”

The proposed rule, which is open to public comment for 60 days, would set up a website that would place all updates for a given drug in one place, minimizing such confusion, Dr. Woodcock said.

The agency said the Supreme Court decision, Pliva v. Mensing, altered the incentives for generic drug companies to conduct adequate monitoring of their drugs because it eliminated the threat of lawsuits from patients who were harmed by those products. In proposing the rule, the agency said it “intended to ensure that generic drug companies actively participate with F.D.A. in ensuring the timeliness, accuracy and completeness of drug safety labeling.”

Dr. Woodcock said she did not expect that generic companies would update their labels frequently, because by the time drugs become available as generics, they have been on the market for years. “It’s not to say that we won’t learn new things, but it becomes less likely to come across new serious adverse events,” she said.